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Published on: December 13, 2018
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma
Meletios A Dimopoulos1, Albert Oriol1, Hareth Nahi1
1From the National and Kapodistrian University of Athens, Athens (M.A.D.); Institut Català d'Oncologia, Institut Josep Carreras, Hospital Germans Trias I Pujol, Barcelona (A.O.), and Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona (J.S.-M.) - both in Spain; Karolinska Institute and the Department of Medicine, Division of Hematology, Karolinska University Hospital at Huddinge, Stockholm (H.N.); Tom Baker Cancer Centre, University of Calgary, Calgary, AB (N.J.B.), and the Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto (D.R.) - both in Canada; Levine Cancer Institute-Carolinas HealthCare System, Charlotte, NC (S.Z.U.); the Department of Haematology, University College London Hospitals NHS Trust, London (N.R.); the Department of Lymphoma-Myeloma, University of Texas M.D. Anderson Cancer Center, Houston (R.Z.O.); the Department of Hematology and Stem Cell Transplantation, Poznan University of Medical Sciences, Poznan, Poland (M.K.); the Department of Hematology, Japanese Red Cross Medical Center, Tokyo (K.S.); Vejle Hospital and University of Southern Denmark, Vejle (T.P.), and Genmab, Copenhagen (S.L.) - both in Denmark; the Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea (S.-S.Y.); the Hematology Department, Hadassah-Hebrew University Medical Center, Jerusalem (D.B.Y.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (P.G.R.); University Hospital Heidelberg and the German Cancer Research Center, Heidelberg, Germany (H.G.); Janssen Research and Development, Spring House, PA (N.Z.K., L.O., C.C., X.Q., M.G., T.A.); and the Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France (P.M.).
Adding daratumumab to lenalidomide and dexamethasone significantly improved progression-free survival for patients with relapsed or refractory multiple myeloma. This combination therapy demonstrated higher response rates and deeper remissions compared to lenalidomide and dexamethasone alone.
Area of Science:
- Hematology
- Clinical Oncology
- Immunotherapy
Background:
- Daratumumab, an immunotherapy agent, has shown promise in treating multiple myeloma.
- Previous studies indicated potential efficacy of daratumumab in combination regimens.
Purpose of the Study:
- To evaluate the efficacy and safety of adding daratumumab to lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.
- To compare progression-free survival (PFS) between the daratumumab combination and lenalidomide-dexamethasone alone.
Main Methods:
- A Phase 3 randomized trial (POLLUX) enrolled 569 patients with relapsed or refractory multiple myeloma.
- Patients received either lenalidomide and dexamethasone alone (control) or in combination with daratumumab.
- Progression-free survival was the primary endpoint.
Main Results:
- The daratumumab group showed significantly longer PFS (hazard ratio, 0.37; P<0.001) with a 12-month PFS rate of 83.2% vs. 60.1% in the control group.
- Overall response rates were higher in the daratumumab group (92.9%) compared to the control group (76.4%).
- Minimal residual disease negativity was achieved in 22.4% of the daratumumab group vs. 4.6% in the control group.
Conclusions:
- Adding daratumumab to lenalidomide and dexamethasone significantly improves PFS in relapsed or refractory multiple myeloma.
- The combination therapy is associated with higher response rates and deeper remissions.
- Adverse events included increased neutropenia and infusion-related reactions in the daratumumab arm.
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